International Clinical Trials

Thursday, September 27, 2007

About

Clinical trials undertaken by U.S. pharmaceutical, biotech, and medical device companies are increasingly being designed as international in scope. However, sponsoring international studies drastically increases the number of legal and regulatory exposures, liabilities, and risks inherent in conducting trials.

Trials in the EU have proven all the more difficult as clinical research professionals struggle to understand the framework of documents containing the requirements of the CT/GCP Directives. Further, accessing populations in India, China, Asia Pacific, Africa, Latin America, and Eastern Europe requires a keen ability to comply with regulatory nuances and overcome language barriers and cultural differences. In addition, the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. Plus, the variability in legal frameworks for advertising, recruiting, reimbursements, data privacy, and human subject protection has made negotiating informed consent documents and drafting international CTAs a constant struggle. With scrutiny by public, private, and political entities higher than ever, there is simply no room for error in spotting, correcting, and minimizing these exposures, liabilities, and risks.

In response, American Conference Institute, creator of the eight-time Clinical Trials conference, presents this publication from its global companion: The Complete Legal and Regulatory Forum on Rigorously Conducting International Clinical Trials. This one-of-a-kind event will provide those charged with managing legal and regulatory risks in conducting international trials with practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

Contents & Contributors

About

Clinical trials undertaken by U.S. pharmaceutical, biotech, and medical device companies are increasingly being designed as international in scope. However, sponsoring international studies drastically increases the number of legal and regulatory exposures, liabilities, and risks inherent in conducting trials.

Trials in the EU have proven all the more difficult as clinical research professionals struggle to understand the framework of documents containing the requirements of the CT/GCP Directives. Further, accessing populations in India, China, Asia Pacific, Africa, Latin America, and Eastern Europe requires a keen ability to comply with regulatory nuances and overcome language barriers and cultural differences. In addition, the globalization of clinical research makes it doubly hard to determine what size and type of CRO to use. Plus, the variability in legal frameworks for advertising, recruiting, reimbursements, data privacy, and human subject protection has made negotiating informed consent documents and drafting international CTAs a constant struggle. With scrutiny by public, private, and political entities higher than ever, there is simply no room for error in spotting, correcting, and minimizing these exposures, liabilities, and risks.

In response, American Conference Institute, creator of the eight-time Clinical Trials conference, presents this publication from its global companion: The Complete Legal and Regulatory Forum on Rigorously Conducting International Clinical Trials. This one-of-a-kind event will provide those charged with managing legal and regulatory risks in conducting international trials with practical and sophisticated strategies, on a region-by-region and country-by-country basis, on producing meaningful and reliable data for marketing approval and protecting the rights of those who participate as subjects. The distinguished faculty includes legal and compliance experts, inside and outside the U.S., from sponsors, CROs, hospitals and research institutions, as well as expert attorneys.

Contents & Contributors

Legal Representative Issues
Maria D. Buckley, Nutter McClennen & Fish LLP (Boston, MA)

EU Clinical Trials Directive
Cristiana Spontoni, Squire, Sanders & Dempsey LLP (Brussels, Belgium)

EU Clinical Trials Directive
Frank Schoneveld, McDermott Will & Emery/Stanbrook LLP (Brussels, Belgium)

Spotlight on Safety in the EU: Evaluating Timely Reporting of Adverse Drug Reactions
Grant H. Castle, Covington & Burling LLP (London)
Rachel Abramovitz, Taro Pharmaceuticals U.S.A., Inc. (Hawthorne, NY)

Securing Valid Informed Consent and Streamlining Ethics Requirements to Avoid Future Complications
Camille P. Wicher, Esq. RN, MSN, Roswell Park Cancer Institute (Buffalo, NY)

International Clinical Trials - Ethical & Oversight Challenges
Professor Fran Miller, Neal M. Pike Scholar, Boston University School of Law; Nutter McClennen & Fish LLP (Boston, MA)

Securing Valid Informed Consent and Streamlining Ethics Requirements to Avoid Future Complications
Jill Alvarez, Nixon Peabody LLP (Washington, DC)

Managing Reputational Risks When Conducting International Clinical Trials
Thomas E. Merchant, GlaxoSmithKline (Philadelphia, PA)

Asian Pacific Rim & Latin America With an Emphasis on Brazil
Melody Lin, PhD, United States Department of Health and Human Services (Rockville, MD)

Complying With Regulatory Nuances When Conducting Trials in Emerging Regions: China
Jennifer Ellis, Arianne Consulting Inc. (San Diego, CA)

Categorizing and Complying With Regulatory Nuances When Conducting Trials in Emerging Regions: Africa, With an Emphasis on Tanzania
Sarah Putney, JD, Harvard School of Public Health (Boston, MA)

Complying With Regulatory Nuances When Conducting Trials in Emerging Regions: India and Russia
Cellia K. Habita, MD, PhD, Arianne Consulting Inc. (San Diego, CA)

Ensuring Protection of Personal Privacy & Transfer of Data Between Jurisdictions
Stephen W. Bernstein, McDermott Will & Emery LLP (Boston, MA)
David S. Szabo, Nutter McClennen & Fish LLP (Boston, MA)
< Jennifer Daniels, Blank Rome LLP

Clinical Trial Data: A Key Element in Product Liability Claims
Joseph K. Hetrick, Dechert LLP (Philadelphia, PA)

Partnering With CROS Abroad: Finding the Right One(s) and Balancing Contractual Control and Convenience
Michael Rogovin, BS, JD, Shire Pharmaceuticals (Wayne, PA)

Partnering With CROS Abroad: Finding the Right One(s) and Balancing Contractual Control and Convenience
Susan M. Flint, M.S., R.A.C., C.C.R.A., C.C.R.P., Cato Research Boston (Waltham, MA)

International Clinical Trial Agreements
Charles E. Yon, Coley Pharmaceutical Group, Inc. (Wellesley, Ma)
Jeffrey M. Delmore, J.D., Genzyme Corporation (Framingham, MA)
Shannon Shanahan, J.D., PATH, Malaria Vaccine Initiative (Seattle, WA)
Amor A. Esteban, Shook, Hardy & Bacon L.L.P. (San Francisco, CA)
Lee W. Farrow, ACE Medical Risk (New York, NY)
Darnell Eric Benjamin, Columbia Presbyterian Medical Center

Forecasting and Developing Clinical Budgets for Running Trials Abroad
Michael G. Eckstein, M+BIOLAW (Philadelphia, PA)
Andrea F. Margiotta, Progenics Pharmaceuticals, Inc. (Tarrytown, NY)

Complying With the FCPA and Overcoming Practical Constraints to Site and Subject Recruitment Internationally
Keith M. Korenchuk, Covington & Burling LLP (Washington, DC)



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